XIENCE Skypoint™ 1804350-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 08717648233418), received between Apr 9, 2021 and May 27, 2026 — classified as 2 deaths, 14 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (24 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 3.5X23 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED AND MET RESISTANCE WITH A GUIDE WIRE. A STRUT BECAME CAUGHT ON THE GUIDE WIRE AND THE STENT MOVED HALFWAY OFF THE DELIVERY SYSTEM. THE DELIVERY SYSTEM BALLOON WAS INFLATED IN ORDER TO KEEP THE STENT ABLE TO BE REMOVED WITH THE DELIVERY SYSTEM. A NEW 3.5X23 MM XIENCE SKYPOINT SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25306282 ↗
• InjuryMay 20, 2026Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 3.5X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH A GUIDELINER; HOWEVER, THE SDS FAILED TO CROSS DUE TO THE ANATOMY. THEREFORE, THE SDS WAS REMOVED FROM THE PATIENT AND DURING REMOVAL RESISTANCE WAS NOTED WITH THE GUIDELINER AND THE STENT BECAME DISLODGED IN THE PROFUNDA ARTERY. THE STENT WAS LEFT IN THE PATIENT. AN UNSPECIFIED DRUG COATED BALLOON (DCB) WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25233131 ↗
• MalfunctionMar 5, 2026Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. THE 3.5 X 23 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE USED ADVANCED TO THE TARGET LESION; HOWEVER, THE SDS FAILED TO ADVANCE DUE TO THE ANATOMY AND THE STENT BECAME DISLODGED FROM THE DELIVERY SYSTEM BALLOON. THE DELIVERY SYSTEM BALLOON WAS ABLE TO BE PUSHED BACK INTO THE STENT AND SLIGHTLY INFLATED TO REMOVE THE DISLODGED STENT FROM THE PATIENT. THE PROCEDURE WAS CONTINUED WITH ANOTHER XIENCE SKYPOINT STENT. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED, AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523907 ↗
• MalfunctionJan 2, 2026Break; Failure to Advance; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY (RCA) LESION. THE XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT THE STENT CAME OFF THE BALLOON AND GOT STUCK IN THE GUIDE LINER. UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23944060 ↗
• MalfunctionDec 30, 2025Break; Difficult to Insert; Device Dislodged or Dislocated; No Apparent Adverse Event; Break; Difficult to Insert; Device Dislodged or Dislocated; No Apparent Adverse Event

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROCEDURE WAS COMPLETED AFTER THIS FAILURE TO CROSS THE LESION. NO OTHER ATTEMPT WAS MADE TO STENT THE PREDILATED, CALCIFIED LESION. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THIS COMPLAINT IS A DUPLICATE OF CN-337875, PREVIOUSLY FILED UNDER MFR# [2024168-2026-00013]. THE COMPLAINT WAS CONFIRMED TO BE A DUPLICATE BASED ON THE FOLLOWING INFORMATION THAT MATCHED: ACCOUNT NUMBER, PROCEDURE DATE, DEVICE LOT NUMBER, PHYSICIAN NAME, TARGET VESSEL, EVENT DETAILS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922646 ↗
• InjuryOct 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN OCTOBER 2022, ONCE 2.5X08MM XIENCE SKYPOINT WAS IMPLANTED IN THE PROXIMAL DIAGONAL, 3.5X23MM, 3.5X12MM, 3.5X15MM XIENCE SKYPOINTS IMPLANTED IN PROXIMAL AND MID RIGHT CORONARY ARTERY (RCA). ANOTHER 3.0X23, 3.0X12MM AND 3.5X08MM XIENCE SKYPOINTS WERE IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITHOUT ISSUE. HOWEVER, IN (B)(6) 2025, THE PATIENT BEGAN TO EXPERIENCE CHEST PAIN AND DIZZINESS. THEREFORE, A STRESS TEST AND ANGIOGRAM REVEALED THE MID RCA AND MID LAD ARE OCCLUDED. PATIENT IS AWAITING BYPASS SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dizziness; Obstruction/Occlusion

  MAUDE report 23270304 ↗
• MalfunctionAug 14, 2025Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE DURING PREPARATION OF THE 3.5X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM, THE YELLOW PROTECTIVE SHEATH WAS REMOVED USING THE STYLET AND THE STENT WAS OBSERVED TO BE PINCHED ON THE DISTAL END. WHEN THE STENT WAS TOUCHED IT CAME OF THE BALLOON; HOWEVER, IT WAS OBSERVED TO BE ALREADY LOOSE PRIOR TO TOUCHING IT. ANOTHER XIENCE SKYPOINT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22808886 ↗
• InjuryJul 8, 2025Stretched; Device Damaged by Another Device; Difficult to Advance; Stretched; Device Damaged by Another Device; Difficult to Advance

  SUBSEQUENT TO THE PREVIOUS FINAL REPORT FILED, AN ADDITIONAL MEDWATCH FORM WAS RECEIVED, MEDWATCH NUMBER IS MW5172946, STATING "WIRE WAS INSERTED INTO THE CIRCUMFLEX LESION. IV US INSERTED BUT WOULD NOT CROSS. PHYSICIAN TRIED BALLOONING VESSEL OPEN. IS US THEN SHOWED HEAVY CALCIFICATION. LITHOTRIPSY PERFORMED. STENT WAS THEN INSERTED BUT WOULD NOT ADVANCE. GUIDE CATHETER INSERTED TO HELP. STENT WAS THEN SUCCESSFULLY PLACED. WHEN TRYING TO REMOVE STENT BALLOON AND WIRE, IT GOT STUCK IN THE STENT STRUTS. INTERVENTION TO REMOVE WAS SUCCESSFUL. PATIENT HARM AVOIDED." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440041 ↗
• MalfunctionApr 28, 2025Material Rupture; Difficult to Advance; Activation Failure; Material Rupture; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MILDLY TORTUOUS RIGHT CORONARY ARTERY THAT IS 90% STENOSED. PRE-DILATATION WAS PERFORMED USING A 2.5MM TREK BALLOON INFLATED AT 6 ATMOSPHERES. DURING ADVANCEMENT OF THE 3.50X23MM XIENCE SKYPOINT DRUG-ELUTING STENT, RESISTANCE WAS MET WITH ANATOMY AND ONCE AT THE LESION WHEN ATTEMPTING TO DEPLOY, THE XIENCE SKYPOINT BALLOON ON THE DELIVERY SYSTEM RUPTURED AT 3 ATMOSPHERES. THE STENT WAS NOT DEPLOYED AND A NEW UNSPECIFIED XIENCE SKYPOINT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922314 ↗
• InjuryApr 28, 2025Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. WHEN ATTEMPTING TO ADVANCE THE 3.5X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM, RESISTANCE WAS FELT WITH THE UNSPECIFIED GUIDELINER AND STENT DISLODGED. AN UNSPECIFIED BALLOON WAS INSERTED AND INFLATED TO BE ABLE TO REMOVE THE STENT WITH GUIDELINER. A NEW GUIDELINER AND STENT WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921954 ↗
• MalfunctionMar 7, 2025Failure to Fold; Difficult to Remove; Failure to Fold; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MILDLY CALCIFIED UNKNOWN CORONARY ARTERY THAT IS 90% STENOSED. A 3.50X23MM XIENCE SKYPOINT DRUG-ELUTING STENT (DES) WAS DEPLOYED. DURING REMOVAL, RESISTANCE WAS FELT WITH ANATOMY AND THE GUIDE CATHETER AS IT WAS OBSERVED THAT THE DES BALLOON LOST ITS SHAPE AFTER DEFLATION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21548688 ↗
• MalfunctionJan 16, 2025Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 75% STENOSED LESION IN THE POSTERIOR TIBIAL ARTERY. A 3.5X23MM XIENCE SKYPOINT DRUG-ELUTING STENT (DES) WAS ADVANCED INTO THE ANATOMY; HOWEVER, THE PROXIMAL SHAFT OF THE DES WAS NOTED TO PUSH THE SHEATH INTO THE AORTA. THE DES WAS REMOVED AND THE SHEATH WAS REPLACED WITH A 90CM SHEATH. AT THIS POINT, THE SAME 3.5X23MM XIENCE DES WAS REINSERTED INTO THE ANATOMY THROUGH THE SHEATH; HOWEVER, THE SHAFT SEPARATED INSIDE THE SHEATH. THE SHEATH ALONG WITH THE SEPARATED PORTION OF THE DEVICE WAS REMOVED AND A NEW SAME SIZED XIENCE SKYPOINT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168281 ↗
• MalfunctionNov 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CIRCUMFLEX CORONARY ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE LESION WAS PRE-DILATED AND THE 3.5X23 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS INFLATED TO NOMINAL PRESSURE AND THE SHAFT WAS WITHDRAWN. IT WAS NOTED ANGIOGRAPHICALLY THAT THE STENT WAS NOT IMPLANTED AND HAD REMAINED ON THE SHAFT OF THE DEVICE OUTSIDE THE PATIENT. A NEW STENT WAS SUCCESSFULLY IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20676049 ↗
• DeathNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.5X23MM XIENCE SKYPOINT DRUG-ELUTING STENT (DES) WAS IMPLANTED IN THE MID CIRCUMFLEX, FOLLOWED BY A 2.5X12MM XIENCE SKYPOINT IN THE OSTIAL CIRCUMFLEX AND CONCLUDING WITH A 2.75X28 XIENCE SKYPOINT IN THE LEFT MAIN. ALL THREE XIENCE SKYPOINT'S WERE IMPLANTED SUCCESSFULLY WITHOUT ISSUE. POST PROCEDURE THE PATIENT BECAME UNRESPONSIVE AND PULSELESS VENTRICULAR FIBRILLATION WAS NOTED. ANGIOGRAM CONFIRMED THROMBOSIS IN ALL THREE IMPLANTED STENTS. THE PATIENT WAS BROUGHT BACK INTO THE CATH LAB AND CPR WAS PERFORMED BUT THE PATIENT EXPIRED. A CLINICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Thrombosis/Thrombus

  MAUDE report 20619917 ↗
• InjuryNov 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT MAIN CORONARY ARTERY WITH MILD CALCIFICATION AND 70% STENOSIS. THE 3.5X23 XIENCE SKYPOINT STENT DELVIERY SYSTEM (SDS) WAS BEING ADVANCED TO THE LESION WHEN THE STENT DISLODGED AND CAME OFF OF THE DELIVERY SYSTEM IN THE LEFT MAIN. A SNARE WAS USED TO RETRIEVE THE STENT. THERE WERE NO ADVERSE PATIENT SEQUELA. ANOTHER XIENCE SDS WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20600022 ↗
• InjuryMar 19, 2024Material Rupture; Difficult or Delayed Activation; Difficult to Advance; Material Rupture; Difficult or Delayed Activation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. PREVIOUS STENT WAS NOTED LEFT MAIN AND IN STENT RESTENOSIS (ISR) IN THE TARGET LESION. ATHERECTOMY WAS PERFORMED WITH A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) IN THE ISR. PRE-DILATATION WAS PERFORMED AND A 3.5X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, MET RESISTANCE WITH ANATOMY. THE STENT DEPLOYED AT 12 ATMOSPHERES; HOWEVER, IT WAS OBSERVED THAT IT KEPT LOSING PRESSURE. THEREFORE, ONCE THE SDS WAS REMOVED, THE STENT REMAINED IN PLACE BUT WAS OBSERVED TO NOT BE FULLY EXPANDED. A 1.5X20MM AND 2.0X20MM BALLOONS WERE USED TO FULLY EXPAND THE STENT. POST DILATATION WAS PERFORMED WITH 3.5X12MM BALLOON. ONCE THE SDS WAS REMOVED FROM THE ANATOMY IT WAS INFLATED AND A HOLE WAS NOTED ON THE SDS BALLOON. THERE WAS NO ADVERSE PATIENT SEQUELA; HOWEVER, THE PATIENT WAS NOT DISCHARGED UNTILL THE FOLLOWING DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18936865 ↗
• MalfunctionFeb 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF THE 3.50X23MM RX XIENCE SKYPOINT DRUG ELUTING STENT SYSTEM (DES) WHEN IT WAS REMOVED FROM THE POUCH IT WAS NOTED THE STENT WAS DISLODGED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18666963 ↗
• MalfunctionJan 8, 2024Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 3.5X23MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION, HOWEVER, FAILED TO CROSS DUE TO THE ANATOMY. THEREFORE, THE DES WAS REMOVED AND RESISTANCE WAS ALSO NOTED WITH THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18469114 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED MODERATELY CALCIFIED, MODERATELY TORTUOUS DISTAL LEFT CIRCUMFLEX LESION. A 3.50 X 23 XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS SUCCESSFULLY IMPLANTED. TWO DAYS AFTER THE STENT WAS IMPLANTED, AN EMERGENT PROCEDURE WAS PERFORMED AS THE PATIENT HAD ATRIAL FIBRILLATION. DEFIBRILLATION WAS PERFORMED AND RED THROMBUS WAS CONFIRMED ON THE DISTAL POSITION OF THE STENT USING OPTICAL COHERENCE TOMOGRAPHY. THE THROMBOSIS WAS TREATED WITH THROMBUS ASPIRATION AND ATHERECTOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Atrial Fibrillation; Thrombosis/Thrombus

  MAUDE report 18360308 ↗
• MalfunctionNov 1, 2023Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS BOTH MODERATELY CALCIFIED AND TORTUOUS AND 90% STENOSED. THE 3.5X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION AND THE TIP OF THE DEVICE BECAME BENT. THERE WAS ALSO RESISTANCE DURING REMOVAL OF THE SDS. A NEW XIENCE STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18052265 ↗
• MalfunctionSep 7, 2023Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE 3.5X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED; HOWEVER, FAILED TO CROSS THE LESION DUE TO ANATOMY. DURING REMOVAL RESISTANCE WAS FELT WITH GUIDE CATHETER AND THE PROXIMAL END OF THE STENT WAS NOTED TO BE FLARED. THE SDS, GUIDE CATHETER AND GUIDE WIRE WERE REMOVED AS A SINGLE UNIT. OUTSIDE THE PATIENT THE SDS WAS WIPED DOWN; HOWEVER, UPON ATTEMPTING TO RE-INSERT IT WAS NOTED THE STENT HAD DISLODGED. THE DISLODGED STENT WAS FOUND ON THE CLOTH USED TO WIPE DOWN THE DEVICE. IT WAS NOTED THAT THE FLARED STENT EDGES LIKELY BECAME CAUGHT ON THE CLOTH WHEN WIPING DOWN THE DEVICE. A NEW 3.5X18MM DRUG ELUTING STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17705166 ↗
• MalfunctionJul 21, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 3.5X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, THE SDS FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. THEREFORE, SDS WAS REMOVED AND RESISTANCE DURING REMOVAL WAS ALSO NOTED DUE TO THE ANATOMY. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17372233 ↗
• MalfunctionJul 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, 90% STENOSED LESION IN THE SAPHENOUS VEIN GRAFT TO THE POSTERIOR DESCENDING ARTERY. PRE-DILATED WAS COMPLETED WITH A COMPLIANT BALLOON, AFTER WHICH A 3.5X23MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. THE BALLOON WAS INFLATED ONE TIME TO 8 ATMOSPHERES (ATM) WITH AN UNSPECIFIED INDEFLATOR DEVICE, HOWEVER THE BALLOON WOULD NOT INFLATE. THE SKYPOINT DEVICE WAS REMOVED WITH THE STENT STILL MOUNTED ON THE BALLOON. A NEW 3.5X23MM SKYPOINT DES WAS USED WITH THE INITIAL INDEFLATOR DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17344715 ↗
• MalfunctionMar 27, 2023Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.50X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, FAILED TO ADVANCE DUE TO THE ANATOMY. THEREFORE, THE SDS WAS REMOVED FROM THE PATIENT AND RESISTANCE WAS FELT ALSO DUE TO THE ANATOMY. AFTER REMOVAL, OF THE SDS THE STENT EDGE WAS NOTED TO BE FLARED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER XIENCE SKYPOINT STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16619708 ↗
• DeathFeb 27, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE PATIENT WAS ON DUAL ANTIPLATELET THERAPY (DAPT) OF ASPIRIN AND PLAVIX, PRE AND POST LOADED PRIOR TO THE CASE. THE PATIENT WAS ON CARDIAC SUPPORT DURING THE PROCEDURE. PRE-DILATATION WAS PERFORMED PRIOR TO IMPLANTING THE 3.5 X 23 MM XIENCE SKYPOINT STENT. THE STENT WAS POST-DILATED TO 4.0MM. THE PATIENT ALSO HAD UNSPECIFIED BLEEDING IN THE ILIAC ARTERY DURING THIS PROCEDURE REQUIRING A COVERED STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16444197 ↗